Italian supplements group sues EU over health claims

Italian food supplements trade group FederSalus has brought an action against the EU nutrition and health claims regulation (NHCR) in European Union courts.

The European Court of Justice (ECJ) will hear that the article 13 claims register is “not understandable”; that the scientific criteria applied by the European Food Safety Authority (EFSA) are inappropriate for validating food-health relationships; and that the evaluation process lacks transparency.

“We believe that the European Legislator should carefully consider that the application of the rule is not working,” said FederSalus president, Germano Scarpa.

“not understandable”

The article 13 claims register that includes 222 permitted and about 1600 non-authorised claims and is enforceable from December 14 this year, will only breed confusion, Scarpa said.

“These claims on the labels of dietary supplements will be not understandable. It could increase the confusion for all consumers. We strongly disagree with the parameters used by EFSA, that are most appropriate for evaluating a drug rather than the health benefits of food supplements.”

“Our association criticises the lack of transparency with the evaluation process.”

The regulation would, he said, “have a serious impact to the business of all Italian companies such as costs for printing again new labels and withdrawal of products from the market.”

It is as yet unknown when the case may be heard.

“Fantasy land”

At a recent health claims congress in the UK, Graham Keen, the executive director of the Health Food Manufacturers Association (HFMA) criticized the application of the article 13 list.

UK publication Natural Products reported he said: “While the THMPD (Traditional Herbal Medicinal Products Directive) had a seven year transition period and a full sell-through period…the NHCR gives just six months, with no specific, defined sell-through. It beggars belief that we have to get this done by December. It’s fantasy land.”

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Italian Supplemen Group Sues EU over Health Claims

It is getting more difficult for supplement companies to survive.
The giant pharmaceutical companies can get away with all kinds of claims and side effects with their products while the supplement companies are driven against the wall. We need a coalition. It is too hard for a single company to deal with all these bureaucrats.